FDA advisors reject MDMA therapy for PTSD, amid concerns over research
A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks.
It represents a major setback for proponents of the drug and its sponsor Lykos Therapeutics, potentially jeopardizing FDA approval of the treatment.
Following public comment and discussion, the panel voted 9-2 that MDMA – in combination with talk therapy – is not effective for treating PTSD. And they voted 10-1 that the benefits of MDMA treatment don’t outweigh its risks.
While the FDA puts stock in the panel’s advice, it does not have to follow their recommendation. However, that would be surprising given the host of concerns raised during the all-day meeting.
Remarks during the meeting from FDA staff and members of the advisory panel highlighted some major shortcomings in the clinical research. These include uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the therapy sessions.
“It seems like there are so many problems with the data,” said Melissa Barone, one of the panelists and a psychologist with the VA Maryland Health Care System. “Each one alone might be okay, but when you pile them up on top of each other...”
Many members of the panel brought up allegations that have surfaced about possible misconduct and bias in the trials that could have skewed the results.
“I have real concerns with the validity of the data and the allegations of misconduct,” said Elizabeth Joniak-Grant, a sociologist and a member of the panel. “I can't in good conscience support something where these many harms are being reported.”
Scientists with the FDA didn’t share details, but acknowledged the agency was investigating some of the claims, which have surfaced in a petition to the agency and outside reports on the trials.
June 7, 2024
